Stakeholder Meeting, 7 th June 2013 Considerations on the assessment of safety data originating from patient support programmes Qun-Ying Yue; MPA, Sweden; PRAC member
Disclaimer • The views presented in this presentation are those of the author and should not be understood or quoted as being made on behalf of the EMA and/or its scientific committees. • Views are presented solely to aid the discussion and should not be interpreted as adopted guidance.
Background • The mandate of the PRAC shall cover all aspects of the risk management of the use of medicinal products for human use including – the detection, assessment, minimisation and communication relating to the risk of adverse reactions, – having due regard to the therapeutic effect of the MP for human use, – the design and evaluation of PASS and pharmacovigilance audit. • PRAC tasks common to both centrally and non-centrally authorised products: • (i) For Union procedures triggered for safety reasons: PRAC recommendation. • (ii) For PSUR single assessment: PRAC shall issue a recommendation. • (iii) For imposed PASS protocols: the PRAC shall issue a letter of endorsement or objection. • (iv) For imposed PASS study results: the PRAC shall issue a recommendation. • (v) For signals: the PRAC shall issue a recommendation. • (vi) For EURD and frequency of PSURs submission: PRAC shall be consulted. • (vii) For list of MP requiring additional monitoring: PRAC shall be consulted. • (viii) For “for cause” pharmacovigilance inspections: PRAC shall issue an advice. PSP stakeholder meeting, 130607 3
Pharmacovigilance data • High quality data collection is a prerequisite for signal detection and assessment. • PSPs are not a single well defined entity but a range of activities • The fundamental legal obligations apply regardless of the juxtaposition of activities involved in any given PSP PSP stakeholder meeting, 130607 4
Individual Case Safety Reports from PSPs • If Individual Case Safety Reports (ICSRs) come from PSPs on an ongoing basis as 15 day reports - what are the issues? • If ICSRs come from PSPs as boluses of data (because they were derived from studies or post hoc data analsys, or as corrective action following non- compliance)? PSP stakeholder meeting, 130607 5
(Hypothetical) Scenario • Medical impact analysis for unreported adverse reactions cases from Patient Support Programmes • Structured analysis /assessment 1. Fatal cases 2. Risks in the RMP or reactions subject to ongoing monitoring/review in PSURs 3. Other important adverse reactions PSP stakeholder meeting, 130607 6
(Hypothetical) Scenario Assessment on B/R impact analysis Uncertainties - cases poorly documented, limited value for signal/risk assessment • Number of PSPs and number of patients included • Follow up if sufficient details available (for patient or reporter) • Cases contain limited information (medical history, time to onset, indication and cause of death). • Reports from non health care professionals • Limited information precludes meaningful causality assessment • Potential impact on BR profile cannot be completely assessed. PSP stakeholder meeting, 130607 7
(Hypothetical) Scenario Conclusions and recommendations on B/R impact analysis Scenario 1 - No further action is required – No issues identified that have impact on ongoing monitoring activities – not warrant an update to PI or RMP. – Overall B/R unchanged and positive. – Monitor certain issues in subsequent PSURs / Continued routine pharmacovigilance. • Reactions are covered in PI. • Low number of cases (vs total number in database); • Isolated reactions; non-serious cases • No new or changing safety signals can be identified PSP stakeholder meeting, 130607 8
(Hypothetical) Scenario Conclusions and recommendations on B/R impact analysis Scenario 2 - Further requests needed: • procedures for ensuring adequate processing and follow-up of cases from PSPs to ensure case quality, to allow a reasonable causality assessment. • approach to identify relevant reactions from the database • measures taken to better document cases. PSP stakeholder meeting, 130607 9
Reflections - Role for PSP reports in signal detection Further questions (1): • What influence do the reports originating from the PSPs have on the overall safety data for signal detection? – Some products have PSPs and others do not. How do reports originating from PSPs impact on the ability to identify potential safety issues in signal detection? – How to integrate PSPs in the routine monitoring of safety of medicinal products? – How to improve the quality of data to help signal detection and safety issue assessment? PSP stakeholder meeting, 130607 10
Reflections - Role for PSP reports in signal detection Further questions (2): • Relative value of ICSRs quality versus ICSRs quantity – What about the quality of the reports? – What are the challenges for causality assessments for the PSPs reports? – Causality assessment is essential for signal detection. – Improved quality of reports from PSPs is essential for assessors. PSP stakeholder meeting, 130607 11
Reflections - Role for PSP reports in signal detection Further questions (3): • The impact of data not being collected or included into global PV systems is an ‘unknown unknown’ and this makes things difficult for assessors and inspectors. • The impact of the data available may be different. • QPPV/pharmacovigilance should have oversight of what arrangements marketing departments and service providers are putting in place for these programmes (and collection of safety data from the programmes). PSP stakeholder meeting, 130607 12
Reflections - Role for PSP reports in signal detection Further questions (4): • How to best arrange the signal detection with the knowledge that there are PSP ongoing for a product? • Can a signal detected from spontaneous reports be ascertained with cases originating from PSPs? • Can a signal with rare events be identified from reports originating from PSPs? • Do we need to wait for new spontaneous reports to react? • Minimum quality of reports is required for safety surveillance of medicinal products, which allow for early identification of safety issues. PSP stakeholder meeting, 130607 13
Reflections - Role for PSPs in Risk Management Plans • Generation of safety data is largely a by-product of PSPs rather than the objective. • If there is a need to demonstrate safety or investigate/ characterise a risk, presumably the preferred option is a well designed study with a clear research question, analysis plan etc. • PSPs should not be used as the principal way to collect safety information in the frame of RMPs. PSP stakeholder meeting, 130607 14
In summary - Role for reports of suspected adverse reactions originating from PSPs • The impact of the data available from PSP may be different. • Causality assessment is essential to report true cases of suspected adverse reactions to competent authorities • Improved quality of reports from PSP is expected. • PSPs should not be the principal mechanism to collect safety information in the frame of RMPs. • Safety concerns should be addressed in the context of well-defined studies with protocols. PSP stakeholder meeting, 130607 15
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